TECNIS IOL ZMB00 (REF ZMB00U0150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474535527), received between Jun 2, 2017 and Jan 22, 2018 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZMB00 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT''S LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE PATIENT HAD DIFFICULTY GETTING USED TO THE LENS AND INTOLERANCE TO THE LENS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE LENS WAS REPLACED WITH A MONOFOCAL LENS, MODEL ZCB00, 14.5 DIOPTER. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING VERY WELL POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7211010 ↗
• InjuryJun 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIALLY, PATIENT WAS EXPERIENCING A MILD FORM OF SHIFTING GLARE IN THE RIGHT EYE. PATIENT WAS ABLE TO TOLERATE THE GLARE IN THE RIGHT EYE, BUT NOT THE LEFT. AS A RESULT THERE WAS NO PLAN FOR A LENS EXCHANGE IN THE RIGHT EYE AT THAT TIME. HOWEVER, THROUGH A RECENT FOLLOW-UP, IT WAS LEARNED THAT THE ZMB00 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT''S RIGHT EYE. THE LENS WAS REPLACED WITH A NON-AMO DEVICE. NO VITRECTOMY WAS NEEDED. HOWEVER, INCISION ENLARGEMENT AND SUTURE WERE REQUIRED. CUSTOMER NO LONGER HAS THE LENS FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6608593 ↗